Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (MAGELLAN-AMD)

June 27, 2023 updated by: Bioeq GmbH

A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

434

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
  • Czechia
      • Hradec Králové, Czechia
        • Research Site
      • Ostrava, Czechia
        • Research Site
      • Pardubice, Czechia
        • Research Site
      • Praha, Czechia
        • Research Site
      • Sokolov, Czechia
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Pécs, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
      • Tatabánya, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Israel
      • Haifa, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Kfar Saba, Israel
        • Research Site
      • Petah tikva, Israel
        • Research Site
      • Rechovot, Israel
        • Research Site
      • Rishon LeZion, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
  • Italy
      • Bologna, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Rozzano, Italy
        • Research Site
      • Udine, Italy
        • Research Site
  • Japan
      • Akita, Japan
        • Research Site
      • Amagasaki, Japan
        • Research Site
      • Asahikawa, Japan
        • Research Site
      • Chiyoda, Japan
        • Research Site
      • Chuo, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukushima, Japan
        • Research Site
      • Hamamatsu, Japan
        • Research Site
      • Himeji, Japan
        • Research Site
      • Hirakata, Japan
        • Research Site
      • Kita, Japan
        • Research Site
      • Kurume, Japan
        • Research Site
      • Meguro, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Nagoya, Japan
        • Research Site
      • Sapporo, Japan
        • Research Site
      • Shinjuku-Ku, Japan
        • Research Site
      • Suita, Japan
        • Research Site
      • Toride, Japan
        • Research Site
      • Yokosuka, Japan
        • Research Site
  • Poland
      • Bielsko-Biala, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Tarnów, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Research Site
      • Kazan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
  • Ukraine
      • Kharkiv, Ukraine
        • Research Site
      • Kherson, Ukraine
        • Research Site
      • Kropyvnytskyi, Ukraine
        • Research Site
      • Luts'k, Ukraine
        • Research Site
      • Odesa, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Zaporizhzhya, Ukraine
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 50 years at Screening.

  • Male or female:

    • Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment.

    • Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

      1. Not a woman of childbearing potential (WOCBP), OR
      2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Willingness and ability to undertake all scheduled visits and assessments.
  • Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD

Exclusion Criteria:

Patients are not eligible for the study if any of the following criteria apply:

  • Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
  • Study eye requiring immediate treatment.
  • Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
  • Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).
  • Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
  • Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
  • Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer.
  • Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
  • Stroke or myocardial infarction within 6 months prior to randomization.
  • Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FYB203 (Proposed aflibercept biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
Drug: FYB203 (Proposed aflibercept biosimilar)
Patients will receive 1 IVT injection of FYB203 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Active Comparator: Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Drug: Eylea® (Aflibercept)
Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in retinal thickness
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Functional changes of the retina
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Proportion of patients who gain or lose pre-specified number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Absence of disease activity
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Concentration of aflibercept in blood
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Change in vision related functioning and wellbeing measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Number of patients with anti-drug antibodies (ADAs)
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year
Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Through study completion, approximately 1 year
Through study completion, approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioeq GmbH

Investigators

  • Study Director: Study Official, Bioeq GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

June 23, 2022

Study Completion (Actual)

May 18, 2023

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYB203-03-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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